A Phase 1/2 Study of HKI-272 (Neratinib) in Combination With Paclitaxel (Taxol) in Subjects With Solid Tumors and Breast Cancer

• Status: Completed
• Trial end date: 2018-02-07
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to learn whether it is safe and effective to administer HKI-272 (neratinib) in combination with paclitaxel in patients with breast cancer.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Puma Biotechnology, Inc.
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel

Criteria

Inclusion Criteria:

Inclusion criteria for both parts of clinical trial:

• Good performance status

• Normal ejection fraction

• Adequate cardiac, kidney, and liver function

• Adequate blood counts

• At least one measurable target lesion

• Negative pregnancy test for female subjects

Inclusion Criteria for Part 1 Only:

• Pathologically confirmed solid tumor not curable with available standard therapy

Inclusion Criteria for Part 2 Only:

• Pathologically confirmed breast cancer

• HER2 positive tumor

• Prior treatment with Herceptin

Exclusion Criteria:

Exclusion criteria for both parts of clinical trial:

• Major surgery, radiotherapy, chemotherapy or investigational agents within two weeks of treatment day 1

• Subjects with bone or skin as the only site of disease

• Active central nervous system metastases

• Significant cardiac disease or dysfunction

• Significant gastrointestinal disorder

• Inability or unwillingness to swallow HKI-272 capsules

• Prior exposure to HKI-272 or other HER2 targeted agents, except trastuzumab (Part 2 only). Prior lapatinib is permitted in arm B of part 2.

• Treatment with a taxane within 3 months of treatment day 1

• Grade 2 or greater motor or sensory neuropathy

• Pregnant or breast feeding women

• Known hypersensitivity to paclitaxel or Cremophor EL

• Prior treatment with anthracyclines with cumulative dose of >400 mg/m^2

• Any other cancer within 5 years with the exception of contralateral breast cancer, adequately treated cervical carcinoma in situ, or adequately treated basal or squamous cell carcinoma of the skin

Exclusion Criteria for Part 2 Only:

• More than 1 (arm A) or 3 (arm B) prior cytotoxic chemotherapy regimen for metastatic disease